Generic outcome set for the international registry on Laser trEAtments in Dermatology (LEAD): a protocol for a Delphi study to achieve consensus on what to measure

IntroductionWhile laser technology has expanded the armamentarium of treatment for various skin diseases during the past years, heterogeneity in study outcomes hampers comparability and appropriate evidence synthesis. Part of these issues can be addressed by developing a generic outcome set. Using the Delphi method, this study aims to seek consensus between key stakeholders on relevant generic outcomes (what to measure) for implementation in the international registry on Laser trEAtments in Dermatology (LEAD). The registry is focused on collecting research data on various laser treatments for skin disorders.Methods and analysisBy reviewing the literature and involvement of key stakeholder groups and adult patients in need or after laser surgery and health professionals, a preliminary list of outcomes will be generated and categorised into domains. Using these outcomes, an international three-round Delphi study will be performed to rate the importance of outcomes in the selection of a generic outcome set. Participants are allowed to provide new outcomes to the preliminary list for revisions during the first Delphi round. Finally, results will be discussed during a consensus meeting to agree on generic outcomes to be used in the LEAD registry.Ethics and disseminationAn ethics approval was not applicable (W19_290 # 18.336). The study is registered with the Cochrane Skin Core OUtcome Set INitiative) and the Core Outcome Measures in Effectiveness Trials initiative. Procedures will be conducted according to the Declaration of Helsinki. The findings will be disseminated through peer-reviewed publications and conference presentations.

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Protocol for the development of a core outcome set for lateral elbow tendinopathy (COS-LET)

Trials ◽

10.1186/s13063-021-05291-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Marcus Bateman ◽

Jonathan P. Evans ◽

Viana Vuvan ◽

Val Jones ◽

Adam C. Watts ◽

...

Keyword(s):

Outcome Measures ◽

Health Care Professionals ◽

Delphi Study ◽

Evidence Synthesis ◽

Core Outcome Set ◽

Outcome Evaluation ◽

Core Outcome ◽

Outcome Set ◽

Lateral Elbow ◽

Lateral Elbow Tendinopathy

Abstract Background Lateral elbow tendinopathy (LET) is a common condition that can cause significant disability and associated socioeconomic cost. Although it has been widely researched, outcome measures are highly variable which restricts evidence synthesis across studies. In 2019, a working group of international experts, health care professionals and patients, in the field of tendinopathy (International Scientific Tendinopathy Symposium Consensus (ICON) Group), published the results of a consensus exercise defining the nine core domains that should be measured in tendinopathy research. The aim of this study is to develop a core outcome set (COS) for LET mapping to these core domains. The primary output will provide a template for future outcome evaluation of LET. In this protocol, we detail the methodological approach to the COS-LET development. Methods This study will employ a three-phase approach. (1) A systematic review of studies investigating LET will produce a comprehensive list of all instruments currently employed to quantify the treatment effect or outcome. (2) Instruments will be matched to the list of nine core tendinopathy outcome domains by a Steering Committee of clinicians and researchers with a specialist interest in LET resulting in a set of candidate instruments. (3) An international three-stage Delphi study will be conducted involving experienced clinicians, researchers and patients. Within this Delphi study, candidate instruments will be selected based upon screening using the Outcome Measures in Rheumatology (OMERACT) truth, feasibility and discrimination filters with a threshold of 70% agreement set for consensus. Conclusions There is currently no COS for the measurement or monitoring of LET in trials or clinical practice. The output from this project will be a minimum COS recommended for use in all future English language studies related to LET. The findings will be published in a high-quality journal and disseminated widely using professional networks, social media and via presentation at international conferences. Trial registration Registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, November 2019. https://www.comet-initiative.org/Studies/Details/1497.

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The development of a faecal incontinence core outcome set: an international Delphi study protocol

International Journal of Colorectal Disease ◽

10.1007/s00384-021-03865-2 ◽

2021 ◽

Vol 36 (3) ◽

pp. 617-622

Author(s):

Sadé Assmann ◽

Daniel Keszthelyi ◽

Jos Kleijnen ◽

Merel Kimman ◽

Foteini Anastasiou ◽

...

Keyword(s):

Systematic Review ◽

Study Protocol ◽

Faecal Incontinence ◽

Delphi Study ◽

Evidence Synthesis ◽

Core Outcome Set ◽

Core Outcome ◽

Delphi Consensus ◽

Link Type ◽

Outcome Set

Abstract Purpose Faecal incontinence (FI) is estimated to affect around 7.7% of people. There is a lack of uniformity in outcome definitions, measurement and reporting in FI studies. Until now, there is no general consensus on which outcomes should be assessed and reported in FI research. This complicates comparison between studies and evidence synthesis, potentially leading to recommendations not evidence-based enough to guide physicians in selecting an FI therapy. A solution for this lack of uniformity in reporting of outcomes is the development of a Core Outcome Set (COS) for FI. This paper describes the protocol for the development of a European COS for FI. Methods Patient interviews and a systematic review of the literature will be performed to identify patient-, physician- and researcher-oriented outcomes. The outcomes will be categorised using the COMET taxonomy and put forward to a group of patients, physicians (i.e. colorectal surgeons, gastroenterologists and general practitioners) and researchers in a Delphi consensus exercise. This exercise will consist of up to three web-based rounds in which participants will prioritise and condense the list of outcomes, which is expected to result in consensus. A consensus meeting with participants from all stakeholder groups will take place to reach a final agreement on the COS. Discussion This study protocol describes the development of a European COS to improve reliability and consistency of outcome reporting in FI studies, thereby improving evidence synthesis and patient care. Trial registration This project has been registered in the COMET database on the 1st of April 2020, available at http://www.comet-initiative.org/Studies/Details/1554. The systematic review has been registered on the PROSPERO database on the 31st of August 2020, available at https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=202020&VersionID=1381336.

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Protocol for the Development of a Core Outcome Set for Lateral Elbow Tendinopathy (COS-LET)

10.21203/rs.3.rs-340653/v1 ◽

2021 ◽

Author(s):

Marcus Bateman ◽

Jonathan P Evans ◽

Viana Vuvan ◽

Valerie Jones ◽

Adam C Watts ◽

...

Keyword(s):

Outcome Measures ◽

Health Care Professionals ◽

Delphi Study ◽

Evidence Synthesis ◽

Core Outcome Set ◽

Outcome Evaluation ◽

Core Outcome ◽

Outcome Set ◽

Lateral Elbow ◽

Lateral Elbow Tendinopathy

Abstract Background Lateral elbow tendinopathy (LET) is a common condition that can cause significant disability and associated socioeconomic cost. Although it has been widely researched, outcome measures are highly variable which restricts evidence synthesis across studies. In 2019 a working group of international experts, health care professionals and patients, in the field of tendinopathy (International Scientific Tendinopathy Symposium Consensus (ICON) Group) published the results of a consensus exercise defining the nine core domains that should be measured in tendinopathy research. The aim of this study is to develop a Core Outcome Set (COS) for LET mapping to these core domains. The primary output will provide a template for future outcome evaluation of LET. In this protocol we detail the methodological approach to the COS-LET development. Methods This study will employ a three-phase approach. (1) A systematic review of studies investigating LET will produce a comprehensive list of all instruments currently employed to quantify treatment effect or outcome. (2) Instruments will be matched to the list of nine core tendinopathy outcome domains by a Steering Committee of clinicians and researchers with a specialist interest in LET resulting in a set of candidate instruments. (3) An International three-stage Delphi Study will be conducted involving experienced clinicians, researchers and patients. Within this Delphi Study candidate instruments will be selected based upon screening using the Outcome Measures in Rheumatology (OMERACT) truth, feasibility and discrimination filters with a threshold of 70% agreement set for consensus. Conclusions There is currently no COS for the measurement or monitoring of LET in trials or clinical practice. The output from this project will be a minimum COS recommended for use in all future English-language studies related to LET. The findings will be published in a high-quality journal and disseminated widely using professional networks, social media and via presentation at international conferences.

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Impact of school-based physical activity interventions in primary schools: measuring what matters

European Journal of Public Health ◽

10.1093/eurpub/ckaa166.1230 ◽

2020 ◽

Vol 30 (Supplement_5) ◽

Author(s):

B Ram ◽

T Venkatraman ◽

K Foley ◽

K Honeyford ◽

L Ells ◽

...

Keyword(s):

Physical Activity ◽

Emotional Health ◽

Evidence Synthesis ◽

Core Outcome Set ◽

Core Outcome ◽

Future Studies ◽

Physical Activity Interventions ◽

School Based ◽

Key Stakeholders ◽

Outcome Set

Abstract Background A growing number of small studies suggest that school-based physical activity initiatives can help children achieve the recommended 60 minutes of physical activity per day. However, the heterogeneity of outcomes and measures used in small studies prevents pooling of results to demonstrate whether short-term health benefits are sustained. Qualitative studies suggest many benefits that are not represented by outcomes in trials to date. The aim of this study was to generate a list of outcomes that have been studied to develop a core outcome set (COS) acceptable to key stakeholders for future studies evaluating school-based physical activity initiatives. Methods We searched six databases (MEDLINE, EMBASE, PsycINFO, CINAHL, CENTRAL and Cochrane Database of Systematic Reviews) systematically for reviews of school-based physical activity interventions, and extracted relevant studies to identify the outcomes and measures used in each paper. A long list was generated from the literature and a previous workshop with stakeholders. This study is registered with COMET (#1322), and with PROSPERO (CRD42019146621). Results 75/121 cited studies drawn from 53/2409 reviews met our inclusion criteria. We grouped 65 outcomes into 3 domains: (i) physical activity and health (ii) social and emotional health, and (iii) educational attainment. We will conduct two Delphi survey rounds with four stakeholder groups (health professionals, researchers, educators and parents) to rate the importance of each outcome. A core outcome set will be generated from a consensus process. Conclusions There is currently a large variation of outcomes and measures studied that precludes evidence synthesis of the impact of school-based physical activity interventions. Consensus methods are needed to focus research on the outcomes that matter the most to key stakeholders and to provide tools for future studies to assess long-term impact. Key messages Variations in outcomes studied precludes evidence synthesis of SBPA intervention impacts. A core outcome set is needed to ensure future SBPA interventions measure outcomes that matter the most.

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The development of a cryptoglandular Anal Fistula Core Outcome Set (AFCOS): an international Delphi study protocol

United European Gastroenterology Journal ◽

10.1177/2050640620907570 ◽

2020 ◽

Vol 8 (2) ◽

pp. 220-226

Author(s):

A.J.H.M. Machielsen ◽

N. Iqbal ◽

M.L. Kimman ◽

K. Sahnan ◽

S.O. Adegbola ◽

...

Keyword(s):

Anal Fistula ◽

Study Protocol ◽

Delphi Study ◽

Evidence Synthesis ◽

Core Outcome Set ◽

Research Quality ◽

Core Outcome ◽

Delphi Consensus ◽

Patient Interviews ◽

Outcome Set

Purpose Cryptoglandular anal fistula is a disorder with an incidence of around 1 per 5,000 people per year in European countries. Many studies have been conducted to evaluate the effectiveness of interventions for anal fistula. However, there is considerable heterogeneity in the outcomes assessed and reported in these studies. This limits research quality and complicates evidence synthesis. A solution for heterogeneity in outcome reporting is the development of a Core Outcome Set (COS). This paper describes the protocol for the development of a European COS for Anal Fistula (AFCOS). Methods The first step will be a systematic review of the literature to identify potential outcomes that may be included in the COS. Patient interviews will be conducted in The United Kingdom and The Netherlands to ensure that both clinician-important and patient-important outcomes are captured. The outcomes will be categorized using the COMET taxonomy and taken forward to a Delphi consensus exercise. In up to three web-based Delphi surveys the outcomes will be prioritized by patients, clinicians (surgeons, gastroenterologists, and radiologists), and (clinical) researchers. The responses will be summarized and reported anonymously in subsequent round(s) facilitating convergence to a consensus opinion. The final COS will be decided during a face-to-face consensus meeting with patients, clinicians, and (clinical) researchers. Discussion This study protocol describes the development of a European COS for anal fistula to improve research quality, evidence synthesis, and patient care.

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The Core Outcome DEvelopment for Carrier Screening (CODECS) study: protocol for development of a core outcome set

Trials ◽

10.1186/s13063-021-05439-7 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Ebony Richardson ◽

Alison McEwen ◽

Toby Newton-John ◽

Karine Manera ◽

Chris Jacobs

Keyword(s):

Systematic Review ◽

Genetic Testing ◽

Core Outcome Set ◽

Carrier Screening ◽

Core Outcome ◽

The Core ◽

Key Stakeholders ◽

Outcome Set ◽

Methods Of Measurement ◽

Genetic Carrier Screening

Abstract Background Reproductive genetic carrier screening is a type of genetic testing available to those planning a pregnancy, or during their first trimester, to understand their risk of having a child with a severe genetic condition. There is a lack of consensus for ‘what to measure’ in studies on this intervention, leading to heterogeneity in choice of outcomes and methods of measurement. Such outcome heterogeneity has implications for the quality and comparability of these studies and has led to a lack of robust research evidence in the literature to inform policy and decision-making around the offer of this screening. As reproductive genetic carrier screening becomes increasingly accessible within the general population, it is timely to investigate the outcomes of this intervention. Objectives The development of a core outcome set is an established methodology to address issues with outcome heterogeneity in research. We aim to develop a core outcome set for reproductive genetic carrier screening to clarify and standardise outcomes for research and practice. Methods In accordance with guidance from the COMET (Core Outcome Measures in Effectiveness Trials) Initiative, this study will consist of five steps: (i) a systematic review of quantitative studies, using narrative synthesis to identify previously reported outcomes, their definitions, and methods of measurement; (ii) a systematic review of qualitative studies using content analysis to identify excerpts related to patient experience and perspectives that can be interpreted as outcomes; (iii) semi-structured focus groups and interviews with patients who have undertaken reproductive genetic carrier screening to identify outcomes of importance to them; (iv) Delphi survey of key stakeholders, including patients, clinicians, and researchers, to refine and prioritise the list of outcomes generated from the previous steps; and (v) a virtual consensus meeting with a purposive sample of key stakeholders to finalise the core outcome set for reporting. Discussion This protocol outlines the core outcome set development process and its novel application in the setting of genetic testing. This core outcome set will support the standardisation of outcome reporting in reproductive carrier screening research and contribute to an evolving literature on outcomes to evaluate genetic testing and genetic counselling as health interventions. COMET core outcome set registration http://www.comet-initiative.org/Studies/Details/1381.

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A protocol for developing a core outcome set for ectopic pregnancy

Trials ◽

10.1186/s13063-021-05772-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Krystle Y. Chong ◽

Sarah Solangon ◽

James Kemper ◽

Kurt Barnhart ◽

Pamela Causa Andrieu ◽

...

Keyword(s):

Ectopic Pregnancy ◽

Randomised Controlled Trials ◽

Core Outcome Set ◽

Future Research ◽

Controlled Trials ◽

Core Outcome ◽

Key Stakeholders ◽

Outcome Set ◽

Core Outcomes ◽

Randomised Controlled

Abstract Background Randomised controlled trials (RCTs) evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an inability to compare results of individual RCTs. The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently will guide future research in ectopic pregnancy. Study aim To develop and implement a core outcome set to guide future research in ectopic pregnancy. Methods and analysis We have established an international steering group of key stakeholders, including healthcare professionals, researchers, and individuals with lived experience of ectopic pregnancy. We will identify potential outcomes from ectopic pregnancy from a comprehensive literature review of published randomised controlled trials. We will then utilise a modified Delphi method to prioritise outcomes. Subsequently, key stakeholders will be invited to score potential core outcomes on a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group convergence towards consensus ‘core’ outcomes. We will also establish standardised definitions and recommend high-quality measurements for individual core outcomes. Trial registration COMET 1492. Registered in November 2019.

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Mental wellbeing in doctors: the measure matters! development of a core outcome set for measuring wellbeing in doctors

BJPsych Open ◽

10.1192/bjo.2021.630 ◽

2021 ◽

Vol 7 (S1) ◽

pp. S235-S236

Author(s):

David Baldwin ◽

Aimee O'Neill ◽

Julia Sinclair ◽

Gemma Simons

Keyword(s):

Health Education ◽

Delphi Study ◽

Research Policy ◽

Core Outcome Set ◽

Care Quality ◽

Mental Wellbeing ◽

Medical Council ◽

Core Outcome ◽

Outcome Set ◽

Health And Social Care

AimsTo achieve a consensus Core Outcome Set for measuring mental wellbeing in doctors.Hypothesis: A minimum set of valid, reliable and practical wellbeing measures is needed for doctors.BackgroundThe importance of doctors’ mental wellbeing to everyone using Health Care is highlighted by the levels of burnout reported in doctors around the world. In 2019 a number of UK policy documents made recommendations for the wellbeing of doctors, but how those wellbeing interventions are evaluated needs to be defined. Core Outcome Sets are increasingly being used in medicine to prevent waste in research, by recommending the inclusion of a minimum set of valid, reliable and practical measures. An operational definition and Core Outcome Set for wellbeing in doctors is needed to meaningfully progress the work in this field.MethodThe Centre for Workforce Wellbeing (C4WW), a collaboration between the University of Southampton and Health Education England, was created to support research into the nature, assessment and enhancement of wellbeing in physicians. A Systematic Review of wellbeing measures used in doctors and the robustness of those measures, along with surveys of 250 UK doctors of all grades and specialities and patient and public involvement is informing what a core outcome set could be. A Delphi Study among 37 UK experts has been initiated to establish the consensus Core Outcome Set.ResultPublication of research into doctors’ wellbeing is growing internationally. In the UK alone data are being captured by multiple national organisations including: the Care Quality Commission, General Medical Council, British Medical Association and the Royal Colleges. Health and Social Care Organisations are, therefore, keen to “do something” and are spending money on wellbeing interventions with little, or no, evidence base and a lack of appropriate, comparable evaluation. A Core Outcome Set for measuring wellbeing in doctors is ethically required to reduce waste, to replace burnout measures and to refine wellbeing interventions.ConclusionWellbeing measures that actually measure wellbeing, and not burnout, which are validated, reliable and practical, are needed to inform local organisational, national government and international research policy. An absence of burnout does not equate to wellbeing. The focus of measurement needs to shift to capture in what contexts we thrive, not just survive. If everyone used the same Core Outcome Set to measure mental wellbeing, direct comparisons could be made, and money invested, in creating infrastructure, processes and cultures that really work.Health Education England funded PhD.

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